Bnb Diagnostics, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 04/24/2025. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D2016 - 42 C. F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C. F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (API) records, the laboratory failed to achieve successful performance in two of three consecutive testing events in 2024 and 2025, resulting in an initial unsuccessful performance for the specialties Bacteriology and Virology. Refer to D2028 and D2064. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records from 2024 and 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty of Bacteriology. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT specialty of Bacteriology: API 2024 Event 2: 0% API 2025 Event 1: 0% 2. A desk review of API proficiency testing records confirmed that the laboratory received the above scores for Bacteriology for 2024 Event 2 and 2025 Event 1. D2064 VIROLOGY CFR(s): 493.831(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records from 2024 and 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty of Virology. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT specialty of Virology: API 2024 Event 2: 0% API 2025 Event 1: 0% 2. A desk review of API proficiency testing records confirmed that the laboratory received the above scores for Virology for 2024 Event 2 and 2025 Event 1. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the specialties of Bacteriology and Virology for two of three consecutive events reviewed in 2024 and 2025. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records, the laboratory director failed to ensure successful performance in two of three consecutive testing events in 2024 and 2025, resulting in an initial unsuccessful performance two of two laboratory's specialties, Bacteriology and Virology. Refer to D2028 and D2064. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/25/2023. The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found in compliance with applicable CLIA conditions, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) records for 2021, the laboratory's records, and staff interview, it was revealed that the laboratory failed to have documentation of the laboratory director signing two of two attestation statements in 2021. Findings include: 1. A review of the laboratory's API records from 2021 revealed the laboratory failed to have documentation of the laboratory director signing the attestation statements for the following two events: - 2021 Immunology /Immunohematology 1st Event - 2021 Immunology/Immunohematology 2nd Event 2. Further review of the above listed API attestation records revealed testing person #1's signature in the areas designated for the Laboratory Director and the Person performing test. 3. A review of the laboratory's records revealed the laboratory failed to have documentation of the laboratory director delegating the responsibility of signing proficiency testing attestation statements to testing person #1. 4. An interview with testing person #1 (as indicated on the CMS 209 form) on 9/27/21 at 9:45 a.m. in the laboratory, after review of the records, confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing evaluation records for 2021, and staff interview, it was revealed that the laboratory failed to have documentation of verifying the accuracy of analytes that were 'not graded' by the proficiency testing program for two of two testing events in 2021. Findings include: 1. A review of the API Proficiency Testing Performance Evaluation form revealed the following: "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for documenting and performing